Abstract
BACKGROUND
Determining high‐risk human papillomavirus (HR‐HPV) status of head and neck squamous cell carcinoma (HNSCC) defines a tumor subset with important clinical implications. Cytologic sampling often provides the sentinel or sole diagnostic specimen. The authors assessed the performance characteristics for the Roche cobas 4800 HPV real‐time polymerase chain reaction (PCR)‐based system (cobas) on cytologic specimens of HNSCC compared with standard methods of in situ hybridization (ISH) for HR‐HPV and immunohistochemistry (IHC) for p16 on formalin‐fixed, paraffin‐embedded (FFPE) tissue.
METHODS
Samples of HNSCC were collected by fine‐needle aspiration and from surgical biopsies or resections, fixed, and processed with the cobas system. Available corresponding FFPE samples were synchronously evaluated for HR‐HPV using ISH and IHC. Discrepant cases underwent additional PCR studies for adjudication.
RESULTS
Thirty‐six samples from 33 patients were analyzed. Forty‐two percent (n = 15) of tumors were positive for HR‐HPV according to cobas. Corresponding histology with ISH (n = 30) was concordant in 91% of samples. Compared with the adjudication PCR standard, there were 3 false‐positive cases according to cobas. Ninety‐two percent (n = 12) of cases were the HPV16 subtype. The overall sensitivity for the cobas system was 100%, and the specificity was 86%.
CONCLUSIONS
Concordance in HNSCC HR‐HPV status between cobas and ISH/IHC was > 90%, and cobas demonstrated a sensitivity of 100% and a specificity of 86%, broadening options for HR‐HPV testing of fine‐needle aspiration samples. Advantages for this system include subtyping of HR‐HPV and the ability to discern HR‐HPV status earlier in a patient's treatment course. Cancer (Cancer Cytopathol) 2014;122:167–174. © 2013 American Cancer Society.
The performance characteristics of the Roche cobas 4800 human papillomavirus (HPV) real‐time polymerase chain reaction‐based system (cobas) were assessed on cytologic specimens of squamous cell carcinoma of the head and neck (HNSCC). Concordance in HNSCC high‐risk HPV status between cobas and in situ hybridization/immunohistochemistry is >90%, and the cobas demonstrates a sensitivity of 100% and a specificity of 86%, broadening options for high‐risk HPV testing of fine‐needle aspiration samples.
